A Pilot Study of Eicosapentaenoic Acid (EPA) in Patients With Cancer Cachexia
Study Details
Study Description
Brief Summary
The data collected through this pilot study will allow us to increase our understanding of cancer cachexia and the effect of Eicosapentaenoic Acid (EPA) on cancer cachexia. Our long-term goal is to improve nutritional treatment and reduce illness in the cancer patient population.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
People who have cancer can get what is called cancer cachexia (CC). The symptoms of CC include getting full quickly when eating (early satiety), loss of appetite, weakness resulting in weight loss and loss of lean body mass. Even a weight loss of 5% in cancer patients reflects poor health, hospitalization, and a higher rate of illness. Research shows that the elderly are at higher risk for deficiency of vitamins and trace minerals. Other pre-existing chronic diseases and drug therapies in this population may increase the needs of certain nutrients. Recent studies have also shown that advanced malnutrition is much more difficult to treat in the elderly than in younger adults, and the consequences of failure to treat it delays recovery and can decrease function and quality of life. At this time, the ways to treat CC include giving medications to increase appetite and giving nutritional supplements that are high in calories and protein.
Recent studies have shown that certain types of fats that are present in fish, walnuts and other foods that we eat called Eicosapentaenoic acid (EPA) may help with weight gain, especially gain in muscle and improve quality of life in patients with pancreatic cancer. However, EPA has never been studied in prevention of cancer cachexia in cancer patients showing early signs of weight loss. Based on these early, small studies, it is clear that we need to study if and how EPA can prevent loss of muscle and weight in cancer patients and prevent this from becoming worse.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Eicosapentaenoic Acid
|
Drug: Eicosapentaenoic Acid
Participants will receive Lovaza at a dose of 4 g for 6 weeks. Participants will be examined at six weeks for change in protein status as indicated by change in morphological (Height, weight, body mass index, body composition, lean body mass, body fat %), and biochemical (serum prealbumin) markers of protein status and immunological cytokines (Il-6, TNF- α) markers implicated in cancer cachexia. At baseline, 3 and 6 weeks, participants will undergo interviews and laboratory analysis for determining compliance and treatment-related toxicity.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Change in Serum Albumin [6 weeks per patient]
Change in protein status at 6 weeks after initial diagnosis of weight loss of >5% body weight as indicated by morphological, biochemical and immunological intermediate biomarkers.
Secondary Outcome Measures
- Number of Participants With Proteasome Activity That Was Inhibited in the Range of 6%-29%. [6 weeks per patient]
There is no expected range for "normal" activity since there is not currently a clinical indication for these molecular markers. Comparison of ranges can be made between groups (such as those that received treatment and not). This was an exploration of potential in the pilot study and further research is indicated to better understand the metabolic abnormalities observed in cancer cachexia as well as potential benefits of using agents such as EPA.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Men and Women 25-80 years of age (inclusive)
-
Confirmed diagnosis of Cancer (other than pancreatic cancer) Unintentional weight loss of >5% of body weight within 3 months of admission to the study
-
Use of effective means of contraception (men and women) in patients of child-bearing potential
-
Normal baseline liver function tests (LFTs) as determined by alanine aminotransferase (ALT) levels. Common Toxicity Criteria (CTC)) version 3 grade 1 elevation in ALT (>Upper Limit of Normal[UNL]-2.5 x UNL) withhold admitting participant to the study until recovery to normal; LFTs will be considered valid for consideration of eligibility if drawn within the previous 2 weeks, otherwise new labs will be drawn.
-
Able and willing to give written informed consent : Each participant must be aware of the nature of his current medical condition and must be willing to give consent after being informed of the experimental nature of therapy, alternatives, potential benefits, side-effects, risks and discomforts.
-
Eastern Cooperative Oncology Group (ECOG) performance status of 0- 2 (Karnofsky score
60%)
- Concurrent use of coumadin or warfarin is okay. The follow-up monitoring for prothrombin (PT), partial thromboplastin time (PTT) and International Normalized Ratio (INR) for patients on warfarin and/or coumadin will follow the standard of care as dictated by the prescribing physician. If the prescribing physician is not a Moffitt physician, then the prescribing physician will be notified by the research staff of the subject participating in the study, and monitors for PT, PTT and INR will be obtained from patient during the 6 week study for review.
Exclusion Criteria:
-
Patients with current diagnosis or history of pancreatic cancer
-
Current use of anticoagulants other than coumadin, warfarin, or aspirin
-
Use of other nutritional supplements other than multivitamins and minerals
-
Allergy to fish or seafood
-
Using Marinol or Megace
-
Known history of hepatic or renal disease
-
Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase risk associated with study participation or study drug administration, or may interfere with interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study.
-
Evidence of bleeding diathesis or coagulopathy
-
Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase risk associated with study participation or study drug administration, or may interfere with interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study
-
Pregnant (positive pregnancy test) or lactating
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Martin Memorial | Stuart | Florida | United States | 34997 |
| 2 | H. Lee Moffitt Cancer Center & Research Institute | Tampa | Florida | United States | 33612 |
Sponsors and Collaborators
- H. Lee Moffitt Cancer Center and Research Institute
- GlaxoSmithKline
Investigators
- Principal Investigator: Nagi Kumar, Ph.D., H. Lee Moffitt Cancer Center and Research Institute
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- MCC-15190
Study Results
Participant Flow
| Recruitment Details | Eligible participants will include cancer patients with Men and Women >25 years of age (inclusive), with a confirmed diagnosis of cancer, unintentional weight loss of >5% of body weight, using uniform established diagnostic criteria and be admitted to the study within 3 month of diagnosis. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Eicosapentaenoic Acid (Lovaza) |
|---|---|
| Arm/Group Description | Participants to receive Lovaza at a dose of 4 g for 6 weeks. |
| Period Title: Overall Study | |
| STARTED | 36 |
| COMPLETED | 14 |
| NOT COMPLETED | 22 |
Baseline Characteristics
| Arm/Group Title | Eicosapentaenoic Acid (Lovaza) |
|---|---|
| Arm/Group Description | Participants to receive Lovaza at a dose of 4 g for 6 weeks. |
| Overall Participants | 36 |
| Age (Count of Participants) | |
| <=18 years |
0
0%
|
| Between 18 and 65 years |
17
47.2%
|
| >=65 years |
19
52.8%
|
| Sex: Female, Male (Count of Participants) | |
| Female |
13
36.1%
|
| Male |
23
63.9%
|
| Region of Enrollment (participants) [Number] | |
| United States |
36
100%
|
Outcome Measures
| Title | Change in Serum Albumin |
|---|---|
| Description | Change in protein status at 6 weeks after initial diagnosis of weight loss of >5% body weight as indicated by morphological, biochemical and immunological intermediate biomarkers. |
| Time Frame | 6 weeks per patient |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Eicosapentaenoic Acid (Lovaza) |
|---|---|
| Arm/Group Description | Participants to receive Lovaza at a dose of 4 g for 6 weeks. |
| Measure Participants | 14 |
| Median (Full Range) [g/dL] |
4.0
|
| Title | Number of Participants With Proteasome Activity That Was Inhibited in the Range of 6%-29%. |
|---|---|
| Description | There is no expected range for "normal" activity since there is not currently a clinical indication for these molecular markers. Comparison of ranges can be made between groups (such as those that received treatment and not). This was an exploration of potential in the pilot study and further research is indicated to better understand the metabolic abnormalities observed in cancer cachexia as well as potential benefits of using agents such as EPA. |
| Time Frame | 6 weeks per patient |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants with available pre and post-treatment serum samples. |
| Arm/Group Title | Eicosapentaenoic Acid (Lovaza) |
|---|---|
| Arm/Group Description | Participants to receive Lovaza at a dose of 4 g for 6 weeks. |
| Measure Participants | 14 |
| Number [Participants] |
9
25%
|
Adverse Events
| Time Frame | 6 weeks per participant | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Eicosapentaenoic Acid (Lovaza) | |
| Arm/Group Description | Participants to receive Lovaza at a dose of 4 g for 6 weeks. | |
All Cause Mortality |
||
| Eicosapentaenoic Acid (Lovaza) | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Eicosapentaenoic Acid (Lovaza) | ||
| Affected / at Risk (%) | # Events | |
| Total | 4/36 (11.1%) | |
| Cardiac disorders | ||
| Hypotension | 1/36 (2.8%) | 1 |
| Gastrointestinal disorders | ||
| Dehydration | 2/36 (5.6%) | 2 |
| Diarrhea | 2/36 (5.6%) | 2 |
| Mucositis/stomach - Oral cavity | 1/36 (2.8%) | 1 |
| Nausea | 2/36 (5.6%) | 2 |
| Vomitting | 2/36 (5.6%) | 2 |
| General disorders | ||
| Febrile Neutropenia | 2/36 (5.6%) | 2 |
| Pain - Chest/Thorax | 1/36 (2.8%) | 1 |
| Pain - abdomen | 1/36 (2.8%) | 1 |
| Metabolism and nutrition disorders | ||
| Glucose serum-high | 1/36 (2.8%) | 1 |
| Potassium serum-low | 2/36 (5.6%) | 2 |
| Respiratory, thoracic and mediastinal disorders | ||
| Dyspnea | 1/36 (2.8%) | 1 |
| Pleural effusion | 1/36 (2.8%) | 1 |
| Pneumonitis | 1/36 (2.8%) | 1 |
| Vascular disorders | ||
| CNS | 1/36 (2.8%) | 1 |
Other (Not Including Serious) Adverse Events |
||
| Eicosapentaenoic Acid (Lovaza) | ||
| Affected / at Risk (%) | # Events | |
| Total | 26/36 (72.2%) | |
| Blood and lymphatic system disorders | ||
| Edema: limb | 1/36 (2.8%) | 1 |
| Hemoglobin | 3/36 (8.3%) | 3 |
| Hemorrhage: nose | 2/36 (5.6%) | 2 |
| International Normalized Ratio of prothrombin time (INR) | 1/36 (2.8%) | 1 |
| Leukocytes (total WBC) | 1/36 (2.8%) | 1 |
| Neutrophils/granulocytes (ANC/AGC) | 1/36 (2.8%) | 1 |
| Partial Thromboplastin Time (PTT) | 1/36 (2.8%) | 1 |
| Eye disorders | ||
| Opthalmoplegia/diplopia (double vision) | 1/36 (2.8%) | 1 |
| Gastrointestinal disorders | ||
| Anorexia | 5/36 (13.9%) | 6 |
| Constipation | 2/36 (5.6%) | 2 |
| Constipation | 1/36 (2.8%) | 1 |
| Diarrhea | 1/36 (2.8%) | 1 |
| Diarrhea | 2/36 (5.6%) | 3 |
| Distension/bloating, abdominal | 1/36 (2.8%) | 1 |
| Mucositis/stomatitis | 2/36 (5.6%) | 2 |
| Nausea | 1/36 (2.8%) | 1 |
| Nausea | 1/36 (2.8%) | 1 |
| Nausea | 8/36 (22.2%) | 9 |
| Taste alteration | 2/36 (5.6%) | 2 |
| Vomiting | 4/36 (11.1%) | 6 |
| General disorders | ||
| Dizziness | 2/36 (5.6%) | 2 |
| Fatigue | 11/36 (30.6%) | 13 |
| Insomnia | 1/36 (2.8%) | 1 |
| Pain - Chest/thorax NOS | 2/36 (5.6%) | 2 |
| Pain - Extremity-limb | 1/36 (2.8%) | 1 |
| Pain - back | 1/36 (2.8%) | 1 |
| Pain - head/headache | 1/36 (2.8%) | 1 |
| Pain - lymph node | 1/36 (2.8%) | 1 |
| Pain - neck | 1/36 (2.8%) | 1 |
| Pain - sinus | 1/36 (2.8%) | 1 |
| Pain - stomach | 1/36 (2.8%) | 1 |
| Rigors/chills | 1/36 (2.8%) | 1 |
| Sweating | 1/36 (2.8%) | 1 |
| Weight loss | 1/36 (2.8%) | 1 |
| Metabolism and nutrition disorders | ||
| Albumin, serum-low (hypoalbuminemia) | 2/36 (5.6%) | 2 |
| Alkaline phosphatase | 2/36 (5.6%) | 2 |
| Glucose, serum-high | 1/36 (2.8%) | 1 |
| Sodium, serum-low | 1/36 (2.8%) | 1 |
| Musculoskeletal and connective tissue disorders | ||
| Muscle weakness | 2/36 (5.6%) | 2 |
| Muscle weakness | 1/36 (2.8%) | 2 |
| Neuropathy: sensory | 1/36 (2.8%) | 1 |
| Renal and urinary disorders | ||
| Urine color change | 1/36 (2.8%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||
| Dyspnea | 3/36 (8.3%) | 3 |
| Nasal cavity/paranasal sinus reaction | 1/36 (2.8%) | 3 |
| Voice changes | 1/36 (2.8%) | 1 |
| Skin and subcutaneous tissue disorders | ||
| Bruising in absence of Grade 3 or 4 thrombocytopenia | 1/36 (2.8%) | 1 |
| Hair loss | 5/36 (13.9%) | 6 |
| Nail changes | 3/36 (8.3%) | 3 |
| Rash | 1/36 (2.8%) | 1 |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Nagi Kumar, Ph.D., via Moffitt Cancer Center |
|---|---|
| Organization | H. Lee Moffitt Cancer Center and Research Institute |
| Phone | 813-745-6885 |
| nagi.kumar@moffitt.org |
- MCC-15190